EU grants approval for expanded use of Tarceva

Roche's personalised medicines push has been boosted after European regulators have another thumbs-up to its oncology blockbuster Tarceva, this time to treat "a genetically distinct type of lung cancer".

The European Commission has approved Tarceva (erlotinib) as a first-line monotherapy in people with locally advanced or metastatic non-small cell lung cancer with EGFR (epidermal growth factor receptor)-activating mutations. The approval is based on data from a Phase III study which demonstrated that in Western patients, first-line Tarceva nearly doubled median progression free survival (9.7 vs 5.2 months) and more than tripled the response rate (58% vs 15%) compared to chemotherapy.

Roche chief medical officer Hal Barron noted that advanced lung cancer is often diagnosed "with little warning of symptoms and progresses aggressively, so it is important to identify which patients may benefit from early treatment with Tarceva". Some 10%-30% of patients with NSCLC have tumours with EGFR activating mutations.

The Basel-headquartered group's Roche Molecular Systems unit is developing a companion diagnostic for the drug to identify patients with EGFR mutations, which should be ready for marketing shortly. Tarceva is already approved in Europe for use ancreatic cancer and in advanced NSCLC irrespective of a patient’s EGFR status both as maintenance treatment in patients with stable disease immediately after initial chemotherapy and for those whose disease has progressed following at least one course of chemotherapy.

The expanded approval for Tarceva, which had first-half sales of 614 Swiss francs (+4%), came as Roche chief executive Severin Schwan stressed Roche's focus on targeted therapies, which will make up half of its portfolio in 10 years.